510(k) · Cleared
ClearedOlympus HDL Cholesterol Reagent; Olympus HDL Cholesterol Calibrator; Olympus HDL/LDL Cholesterol Control Sera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Feb 8, 2002 after a 65-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 8, 2002
- Review
- 65 days
- Class
- Class I
- Product code
- LBS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LBS devicesLBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBS
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · LBS
118in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBS
6in 2025
MAUDE reports naming product code LBS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 3 | 129 | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 3 | 118 | 0 | 3 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Olympus HDL Cholesterol Test System contains HDL Cholesterol Reagent, HDL Cholesterol Calibrator, and Assayed HDL/LDL Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of HDL Cholesterol concentrations in human serum and plasma. The Olympus HDL Cholesterol Calibrator is a lyophilized human serum intended to provide an HDL concentration of known value for use in…
Read the full statement (142 words)
The Olympus HDL Cholesterol Test System contains HDL Cholesterol Reagent, HDL Cholesterol Calibrator, and Assayed HDL/LDL Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of HDL Cholesterol concentrations in human serum and plasma.
The Olympus HDL Cholesterol Calibrator is a lyophilized human serum intended to provide an HDL concentration of known value for use in calibration of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
The Olympus HDL/LDL Cholesterol Control consists of lyophilized human sera. These assayed control sera are designed to monitor the recovery and precision of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.
HDL Cholesterol demonstrates a strong and independent association with the risk of coronary artery disease and is used in the initial screening for hypercholesterolemia.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014015 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014015: Olympus HDL Cholesterol Reagent; Olympus HDL Cholesterol Calibrator; Olympus HDL/LDL Cholesterol Control Sera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014015
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026